BUPROPION HYDROCHLORIDE

Product NDC
42806-410
11-digit product format
428060410
Labeler code
42806
Product ID
42806-410_af1a3522-8180-4e3f-a2fc-c9fe143997a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPROPION HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Epic Pharma LLC
Application
ANDA075932
Marketing category
ANDA
Marketing start
2021-12-15
Substance
BUPROPION HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BUPROPION HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPROPION HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZG7E5POY8O
Rxcui993503, 993518, 993536

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4eceb285-f3c7-4092-a21a-4c9f3169f20cProduct name520260220
548ba7fd-fd0c-4a21-b2b0-d01bf93143b8Product name320240209
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
b8ee525f-67fb-39fb-91da-7e47ac54581dProduct name520200611
98e65af1-f5d0-75d5-c930-f8a4ce4c3284Product name920190211
e4d463bc-c674-43cb-be06-82786f310d01Product name120150326
0916dcfb-331f-89b1-8eac-6f7dc76d82daProduct name120140508
d7fc3d53-5a6c-de82-2808-1780f175f17eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-410-01BUPROPION HYDROCHLORIDE100 in 1 BOTTLETABLET, EXTENDED RELEASE1005
42806-410-05BUPROPION HYDROCHLORIDE500 in 1 BOTTLETABLET, EXTENDED RELEASE5005
42806-410-60BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-410-01EA - Each42806-410b9cf194a-fb98-4717-9e80-9f80a0d4b84d12022-01-06
42806-410-05EA - Each42806-410a69b3cdd-097f-4fe0-8aa2-2c5c581283d212022-01-06
42806-410-60EA - Each42806-410208e4c23-0d30-431d-b325-9d33ccef9c5b12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-410BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [EPIC PHARMA LLC]4Current NDC, Legacy NDC, 3 package rows20231221_9fb44e96-6160-4a4a-90cb-91764c0dcd89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993503buPROPion HCl 100 MG 12HR Extended Release Oral TabletPSN9fb44e96-6160-4a4a-90cb-91764c0dcd895
993518buPROPion HCl 150 MG 12HR Extended Release Oral TabletPSN9fb44e96-6160-4a4a-90cb-91764c0dcd895
993536buPROPion HCl 200 MG 12HR Extended Release Oral TabletPSN9fb44e96-6160-4a4a-90cb-91764c0dcd895
99350312 HR bupropion hydrochloride 100 MG Extended Release Oral TabletSCD9fb44e96-6160-4a4a-90cb-91764c0dcd895
99351812 HR bupropion hydrochloride 150 MG Extended Release Oral TabletSCD9fb44e96-6160-4a4a-90cb-91764c0dcd895
99353612 HR bupropion hydrochloride 200 MG Extended Release Oral TabletSCD9fb44e96-6160-4a4a-90cb-91764c0dcd895
993503bupropion HCl 100 MG 12 HR Extended Release Oral TabletSY9fb44e96-6160-4a4a-90cb-91764c0dcd895
993518bupropion HCl 150 MG 12 HR Extended Release Oral TabletSY9fb44e96-6160-4a4a-90cb-91764c0dcd895
993536bupropion hydrochloride 200 MG 12 HR Extended Release Oral TabletSY9fb44e96-6160-4a4a-90cb-91764c0dcd895

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-410-0142806041001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-410-01) 2021-12-150000-00-00NoNoCurrent
42806-410-0542806041005500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-410-05) 2021-12-150000-00-00NoNoCurrent
42806-410-604280604106060 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-410-60) 2021-12-150000-00-00NoNoCurrent